Weight loss drug may reduce risk of stroke, heart attack
Video with this story is from News 8’s “Daybreak” on March 29, 2024.
(CNN) — Wegovy’s not just for weight loss anymore.
The U.S. Food and Drug Administration on March 8 approved drugmaker Novo Nordisk’s application to add cardiovascular benefits to the medicine’s label, making it the first weight-loss drug to also be cleared to reduce the risk of heart attack, stroke, or heart-related death in people at higher risk of these conditions.
The label expansion may improve insurance coverage for Wegovy, which costs more than $1,300 per month out of pocket before any discounts. Many insurers, including Medicare, don’t cover drugs for weight loss, leaving patients scrambling to afford them.
The approval is based on a 17,000-patient study that showed that people taking Wegovy, the sister drug to the better-known Ozempic, had a 20% lower risk of a cardiac event than those taking a placebo.
WISH-TV medical expert Dr. Janel Gordon said March 29, 2024, on “Daybreak,” “Last year, a published study came out and showed us that will go now actually has FDA approval for heart disease. So, what they found in a study of over 17,000 patients who were studied for almost three years had a 27% decrease in heart disease. They had a 7% decreased risk of and about 15% decreased risk of death from heart-related conditions.”
Wegovy is indicated for people with a body mass index of at least 30 – considered to have obesity – or those with a BMI of at least 27 – considered overweight – and at least one “weight-related” health condition like high blood pressure or cholesterol. Ozempic is approved for type 2 diabetes. Both use the active ingredient semaglutide, part of a class of drugs known as GLP-1 receptor agonists.
“Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,” Dr. John Sharretts, the FDA’s director of the Division of Diabetes, Lipid Disorders, and Obesity, said in a news release from the agency.
“This patient population has a higher risk of cardiovascular death, heart attack, and stroke,” he added. “Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”
Novo Nordisk’s trial was done in people with cardiovascular disease, meaning they had a previous heart attack or stroke or symptoms of peripheral artery disease – clogged arteries in the arms or legs. More studies need to be done to show whether there are heart benefits for people who haven’t had a cardiac event.
Wegovy continues to be in shortage, along with other GLP-1 medicines, as drugmakers struggle to keep up with demand. Novo Nordisk said last month that it’s gradually increasing the supply over the course of this year.
“The shortages are really, really bad right now,” Dr. Jody Dushay, an endocrinologist at Beth Israel Deaconess Medical Center and an assistant professor of medicine at Harvard Medical School, said Friday. She said she has no affiliations with drugmakers.
She said she hoped the expanded approval would improve insurance coverage, particularly as generic weight-loss drug alternatives can carry heart risks, but noted that “if insurance comes on board with this indication,” she has “no idea how manufacturing will ever catch up.”
But, Dushay added, “this might also help prioritize use of [the drugs] among those with highest-risk obesity,” those who also have cardiovascular disease.
Novo Nordisk’s head of North America Operations, Doug Langa, said in Friday’s news release that the company is working “to increase manufacturing capacity to responsibly supply this important medicine.”
Some leading U.S. obesity specialists have said they expected Lilly’s weight-loss drug Zepbound would produce similar heart benefits as Wegovy because both belong to the same class of medications.
Indianapolis-based Lilly is expected to publish results from a late-stage trial testing Zepbound as a treatment for heart failure sometime this year.